!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 44: In-Process Controls 21 CFR 211.110 and Eudralex Volume 4 21 CFR 211.110 “Sampling and Testing of In-process Materials and Drug Products”;…
Sanitization and Hygiene Clean areas should be cleaned thoroughly according to documented procedures. Detailed hygiene programs should be established. They should include procedures relating to the health, hygiene practices,…
Though not a compendial specification, the PhEur suggests a total aerobic microbial count (TAMC) action limit of 10 CFU/100 mL in its WFI monograph, which agrees with the 1993…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 41: Salvaged/Returned Goods and Destruction Good manufacturing practices (GMP) regulations were designed to ensure that pharmaceutical products that are manufactured and released…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 42: Master Batch and Completed Batch Records Clearly written, detailed batch records are critical to ensuring product quality. The master batch record…
The principles of conducting an analytical OOS investigation heretofore described should be invoked throughout an MDD investigation, including proper documentation, collection of data, and interpretation of data by the…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 39: Shipping and Distribution A finished pharmaceutical’s labeling and/or pharmacopeia monograph provide specific directions for the temperature and humidity conditions of storage…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 38: Material Storage, Identification, and Rotation Material Storage Storage locations should meet the general principles outlined for pharmaceutical manufacturing facilities in each…
!DOCTYPE html PUBLIC “-//W3C//DTD XHTML 1.1//EN” “http://www.w3.org/TR/xhtml11/DTD/xhtml11.dtd”> Chapter 37: Sampling Processes General Sampling Requirements It is desirable to have written procedures for sampling that include the names of person(s) authorized…
First-Party Audits Internal audits are performed according to a schedule to evaluate the quality system in order to determine if it is effectively implemented and maintained. In addition, they…
